MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-18 for VITEK32 * manufactured by Biomerieux Vitek, Inc.
[18963389]
Ups for vitek32 became very hot and smelled like "hot wiring". There had been a short power interruption the previous night. It appeared to be operating on battery mode even though electricity had been restored. Technical services said to disconnect immediately after going through check points. Vitek shipped a new ups overnight and was system fully restored.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 569110 |
| MDR Report Key | 569110 |
| Date Received | 2005-01-18 |
| Date of Report | 2005-01-12 |
| Date of Event | 2004-12-09 |
| Report Date | 2005-01-12 |
| Date Reported to FDA | 2005-01-18 |
| Date Added to Maude | 2005-02-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK32 |
| Generic Name | MICROBIOLOGY SYSTEM |
| Product Code | LIB |
| Date Received | 2005-01-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 558958 |
| Manufacturer | BIOMERIEUX VITEK, INC |
| Manufacturer Address | 595 ANGLUM ROAD HAZLEWOOD MO 63042 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-18 |